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In your studies 'Drug Regulator Affairs'

©Volker Lannert / Universität Bonn

Master's thesis


As part of the continuing education Master's degree programme, Master's theses are written on relevant topics in the field of 'Drug Regulatory Affairs' using scientific methods. The topics are highly topical, diverse and the results are both of interest in a scientific context and relevant to many areas of activity in 'Drug Regulatory Affairs'.

Here you will find all Master's theses written since the year 2000, including the title and a summary. In this collection, many Master's theses can also be viewed and downloaded in full text.

Further information on Master's theses (e.g. registration, processing) can be found in our ‘Master's thesis guidelines/Leitfaden für die Anfertigung einer Masterarbeit’ (in German) and in the ‘Information leaflet - Master's thesis’ at

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Do you have any questions or are you interested in the full text of a Master's thesis that is not listed here?
Please feel free to contact me.

Dr. Jasmin Fahnenstich

Dr. Jasmin Fahnenstich

Study programme manager

Phone: +49 (0) 228 - 9268 6806

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Master's thesis

The collection of Master's theses can be searched and sorted by entering keywords.

Year Name Title Full text Summary
2017 Andre Zernov Regulation of the pharmaceutical market in the EAEU, Russia and Ukraine: Similarities and differences
2016 Silvia Balogh Extensions of indication in the European Union - a regulatory overview ***
2016 Dr. Dagmar Behnke Implementing the new Pharmacovigilance legislation - challenges for the pharmaceutical industry ***
2016 Dr. Mayte Bewersdorff Biosimilars in the U.S. - the long way to their first approval ***
2016 Manuel Bilke EMA Clinical Data Transparency: A Critical Synopsis ***
2016 Dr. Stefanie Blättermann Structured Product Labeling standard: A tool for IDMP implementation and electronic package leaflet creation?
2016 Dr. Iris Bruchmüller Cannabis for medicinal and recreational purposes and new psychoactive substances – Critical review of recent legal initiatives in Germany ***
2016 Dr. Sarah Büchner Coping with Drug Shortages through regulatory governance: Approaches and perspectives to a complex global challenge ***
2016 Dr. Henrietta Dehmlow eCTD submissions - a global reality already? ***
2016 Dr. Konstanze Eisfeld PRIority MEdicines (PRIME) – a scheme by the EMA to accelerate the development of medicines that target an unmet medical need
2016 Annette Fries Regulatory Intelligence: How public information available in the internet can support a development strategy ***
2016 Wolfgang Gulbins Between Standardisation and Flexibility - Defining Granularity of the eCTD Module 3.2.S for Different Types of Drug Substances in Europe ***
2016 Tanja Hanikel Registration procedure for medical devices in the Russian Federation – under consideration of the new EEU regulations
2016 Thomas Haupt Data and knowledge management optimization by introduction of a new Collaboration Tool (Microsoft SharePoint) in the Regulatory Affairs Department of a mid-sized pharmaceutical company
2016 Dr. Niklas Jänich Paediatric Drug Development from a Labeling Perspective - A detailed view on the European Summary of Product Characteristics with an exemplary comparison to the US Prescribing Information ***
2016 Helene Janzen Forced degradation studies - comparison between ICH, EMA, FDA and WHO guidelines and ANVISA's resolution RDC 53/2015 ***
2016 Regina Kaiser Recent Developments on the EU-Regulatory Approach in mobile Health regarding mobile Health Apps which can be "medical Apps" or "non medical Apps" ***
2016 Dr. Anja Kassner Harmonization of Regulated Product Submissions for Medical Devices - International Medical Device Regulators Forum Table of Content concept
2016 Martina Kirsch Epigenetic Research bridges Clinical Research Gaps in Schizophrenia: Epigenetic Biomarker Development and Informed Consent Process Considerations in Clinical Trials
2016 Almut Koch The worldwide challenge of antibiotic resistance. Strategies in Europe and USA from a regulatory point of view
  • Total: 969